Pharmaceutical Microbiology: Cleanroom cleanliness classes

Pharmaceutical Microbiology: Cleanroom cleanliness classes

Air Filtration to Control Contamination
ISO 14644-1 Class		Recommended filtration
ISO Class 9		Equivalent to level 1 or Pharmaceutical condition: G4 filters
ISO Class 8		Production facility operating on 100% outside air: G4 and F8 filters
ISO Class 8		Production facility operating on recirculated plus ambient air: where potential for product cross-contamination exists. G4,F8 &H13 filters
ISO Class 7		Facility operating on recirculated air or 100% ambient air:G4,F8 & H13 filters(HEPA filters may be located terminally or in AHU)
ISO Class 6		Facility operating on recirculated air or 100% ambient air:G4,F8 & H13 filters(HEPA filters to be terminally located.)
ISO Class 5		Facility operating on recirculated air or 100% ambient air:G4,F8 & H13 filters(HEPA filters to be terminally located.)
The filter classifications referred to above relate to the EN1822 and EN779 test standards
which are the latest filter test standards, recommended for international use. (EN 779 relates
to filter classes G1 to F9 and EN 1822 relates to filter classes H10 to U16.)

ISO Class 1
ISO Class 2
ISO Class 3	M1 & M1.5	1
ISO Class 4	M2 & M2.5	10
ISO Class 5(L)	M3 & M3.5	100 (L)	Class A
ISO Class 5(T)	M3.5	100(T)	Class A
ISO Class 6	M4.5 & M5	1000	Class B
ISO Class 7	M5 & M5.5	10 000	Class C
ISO Class 8	M6 & M6.5	100 000	Class D
ISO Class 9	M7	1,000,000	Class E